First chewable oral contraceptive

FDA Consumer, March-April, 2004

A first-of-its-kind tablet is the latest addition to the selection of oral contraceptives available to women. Ovcon 35, approved by the FDA in November 2003, is a spearmint-flavored tablet that can be chewed or swallowed whole.

Ovcon 35 contains a progestin (norethindrone) and an estrogen (ethinyl estradiol), ingredients found in contraceptive products that are already marketed. Directions for use tell women that if the pill is chewed and then swallowed, they should drink an 8-ounce glass of liquid immediately afterwards so that the full dose of medication reaches the stomach and no residue is left in the mouth.

Risks associated with Ovcon 35, manufactured by Bristol-Myers Squibb Co. of Princeton, N.J., are similar to those of all birth control pills and include an increased risk of blood clots, heart attack, and stroke. The product labeling also warns that cigarette smoking by women, especially those older than 35, increases the risk of serious cardiovascular side effects from use of combination hormonal contraceptives.